BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Reported: December 28, 2016 Initiated: November 2, 2016 #D-0207-2017
Product Description
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Reason for Recall
Failed Dissolution Specifications; 6 month time point
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 16,356 bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 16,356 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; 6 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Low. Recall number: D-0207-2017.
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